a trial to investigate efficacy, safety and tolerability of fe 201836 for nocturia due to nocturnal polyuria in adults

Conditions: Nocturia

Summary: the purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of fe 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults


Eligibility criteria:
inclusion criteria: * adults ≥18 years of age (at the time of written consent) * medical history of, or subject reported nocturia symptoms during the 6 months prior to visit 1 * ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-diary prior to visit 2 * the largest single voided volume must be ≥200 ml (at least 1 void ≥200 ml) as documented in the 3-day e-diary prior to visit 2 * nocturnal polyuria, defined as nocturnal polyuria index \>33%, a ratio of nocturnal urine volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-diary prior to visit 2 * ≥20% decrease in the nocturnal diuresis rate (ml/min) (that was recorded at visit 2) as documented in the 3-day e-diary prior to visit 3 exclusion criteria: * current diagnosis of obstructive sleep apnoea (osa) * restless legs syndrome (rls) * bladder outlet obstruction (boo) or urine flow \<5 ml/s, as confirmed by uroflowmetry upon suspicion during screening prior to visit 2 * urinary incontinence defined as an average of \>1 episode/day in the 3-day e-diary prior to visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary) * any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to visit 1. including e.g., transurethral resection for bladder outlet obstruction or benign prostatic hyperplasia, hysterectomy or female incontinence procedures * genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms * a history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to visit 1, except for adequately treated basal cell carcinoma of the skin * history of any neurological disease affecting bladder function or muscle strength (e.g., multiple sclerosis, parkinson's, spinal cord injury, spina bifida) * habitual (fluid intake \>3l per day) or psychogenic polydipsia * uncontrolled hypertension, as judged by the investigator * uncontrolled diabetes mellitus, as judged by the investigator * central or nephrogenic diabetes insipidus * known history of syndrome of inappropriate antidiuretic hormone (siadh) secretion * history of gastric retention * suspicion or evidence of congestive heart failure, (new york heart association (nyha) class ii, iii, iv) * hyponatraemia: * serum sodium level \<135 mmol/l at visit 1(re-tested, with results available within 7 days) * serum sodium level \<130 mmol/l at visit 3 (re-tested, with results available within 7 days) * use of any prohibited therapy listed below: * current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (imp) * unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable) * thiazide diuretics * antiarrhythmic agents * v2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin) * loperamide * botulinum toxin (cosmetic non-urological use is acceptable) * valproate